FDA UDI
In Commercial Distribution
🇺🇸 United States
Myo Unit
DI: 08057971591053
·
Model: MU01-01
·
BIONIT LABS SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Myo Unit
- Primary DI
- 08057971591053
- Version / Model
- MU01-01
- Company Name
- BIONIT LABS SRL
- Labeler DUNS
- 439080477
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-13
- Public Version
- 1
- Public Version Date
- 2024-11-21
- Public Version Status
- New
- Public Device Record Key
- 80ee65e9-1c2f-4836-9761-27c3248a7b2a
Device Description
Device for displaying surface EMG signal intensity from active electrodes
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HCJ | Device, Skin Potential Measurement | Neurology | 882.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11474 | Electromyograph | An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08057971592739 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 08057971591053 | GS1 |
Customer Contacts
- Phone
- +3908361946903
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 45 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 35 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 45 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 35 Degrees Celsius